CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004

K974454 · Tucson Medical Corp. · OCT · Dec 18, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K974454
• Device Name: CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004
• Applicant: Tucson Medical Corp.
• Product Code: OCT · Gastroenterology, Urology
• Decision Date: Dec 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Intended for use as an agent to keep external viewing surfaces clear of water vapor and condensation.

Device Story

ClearField Anti-Fog Sterile Wipe consists of a sterile cloth pre-saturated with 5cc of anti-fog solution. Device is for single use. Used by clinicians to wipe external viewing surfaces of medical instruments (e.g., endoscopes) to prevent water vapor and condensation buildup, ensuring clear visualization during procedures. Benefits patient by maintaining optical clarity during clinical interventions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterile cloth pre-saturated with 5cc anti-fog solution. Single-use. No electronic components or software.

Indications for Use

Indicated for use as an agent to keep external viewing surfaces clear of water vapor and condensation. Prescription use only.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• ClearField Anti-Fog Sterile Wipe (K904871/B)

Submission Summary (Full Text)

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K974454
P1091

# 4. Safety and Effectiveness 510(k) Summary

DEC 18 1997

Date Prepared: November 20, 1997

Submitted By:
Tucson Medical Corporation
3941 East 29th Street, Suite 601
Tucson, AZ 85711
Phone: (520) 512 - 1100, Fax: [phone]
Contact Person: Douglas Bueschel

Trade name: ClearField Anti-Fog Sterile Wipe, Product Number 300-004.

Common name: External Lens Anti-Fog Solution.

Classification name: Endoscope Accessory (per 21 CFR section 876.1500).

Predicate Device: ClearField Anti-Fog Sterile Wipe, 510(k) Number K904871/B.

Device Description: Sterile cloth pre-saturated with 5cc of Anti-Fog solution. Single Use.

Intended Use: Intended for use as an agent to keep external viewing surfaces clear of water vapor and condensation.

Substantial equivalence is based upon equivalent technological characteristics of the solution, cloth and ink of this device compared to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

DEC 18 1997

Mr. Jim Patko
Operations Manager
Tucson Medical Corporation
3941 East 29th Street, Suite 601
Tucson, Arizona 85711

Re: K974454
Clear-Field Anti-Fog Sterile Wipe (Product Number 300-004)
Dated: November 20, 1997
Received: November 25, 1997
Regulatory class: II
21 CFR §876.1500/Product code: 78 KOG

Dear Mr. Patko:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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Page ___ of ___

510(k) Number (if known): K974454

Device Name: ClearField Anti-Fog Sterile.Wipes

Indications For Use:

ClearField Anti-Fog Sterile Wipe is intended for use as an agent to keep external viewing surfaces clear of water vapor and condensation.


(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert D. Sittling
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974454

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)